ROLE OVERVIEW

A leading biotech company based in the Oxfordshire area is seeking a dedicated Senior Validation Engineer to join their dynamic validation team. This role offers the chance to work in a cutting-edge environment, ensuring that equipment, utilities, instrumentation, and computerised systems are qualified and maintained in a validated state in accordance with regulatory guidance. The Senior Validation Engineer will collaborate with internal customers and external contractors to coordinate scheduling, execution, and review of qualification protocols and reports.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior Validation Engineer will be varied however the key duties and responsibilities are as follows:

1. Establish, revise, and maintain validation plans and procedures for the qualification of equipment required for cGMP compliance.

2. Write and execute qualification protocols and generate reports, including acceptance criteria.

3. Coordinate scheduling, execution, and review of qualification protocols and reports.

4. Manage vendors and contractors performing qualification activities.

ROLE REQUIREMENTS:

To be successful in your application to this exciting role as the Senior Validation Engineer we are looking to identify the following on your profile and past history:

1. Relevant degree in a scientific or engineering discipline.

2. Proven industry experience in validation within a biotech or pharmaceutical environment.

3. A working knowledge and practical experience with cGMP, ALCOA principles, and computer system validation (CSV).

Key Words:

Senior Validation Engineer / biotech / Oxford / validation plans / cGMP compliance / qualification protocols / computer system validation / CSV / data integrity assessments / equipment requalification / ALCOA principles / change control

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.